[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"secondary-progressive-multiple-sclerosis-spms\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:secondary-progressive-multiple-sclerosis-spms":28},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,6,0,[8,53,67,104,132,157],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":29,"overallStatus":40,"whyStopped":4,"lastUpdateSubmitDate":41,"lastUpdatePostDateStruct":42,"startDateStruct":45,"completionDateStruct":47,"leadSponsor":49,"locationsCount":52},"100053289","phase-3-a-study-to-evaluate-the-efficacy-and-safety-of-remibrutinib-in-secondary-progressive-multiple-sclerosis-100053289",false,"NCT07225504","A Study to Evaluate the Efficacy and Safety of Remibrutinib in Secondary Progressive Multiple Sclerosis","A Randomized, Double-blind, Placebo-controlled Phase III Study to Evaluate the Efficacy and Safety of Remibrutinib in Patients With Secondary Progressive Multiple Sclerosis","REMASTER","Inclusion Criteria:\n\n* Signed informed consent must be obtained prior to any assessment performed.\n* Male or female participants aged 18-65 (inclusive) at Screening.\n* Diagnosis of MS according to the 2017 revised McDonald criteria (Thompson et al 2018), with current SPMS in accordance with the revised clinical course (Lublin et al 2014) at Screening\n* Absence of documented clinical relapses in the 24 months before Screening and randomization.\n* EDSS score of 3.0 to 6.0 (inclusive) at Screening.\n* Documented evidence of disability progression in the 12 months before Screening.\n\nExclusion Criteria:\n\n* Unwilling or unable to undergo MRI scans as per protocol (for example, claustrophobia, or presents absolute contraindications to MRI (e.g., metallic implants, metallic foreign bodies, pacemaker, defibrillator)).\n* History of clinically significant central nervous system (CNS) disease (e.g. stroke, traumatic brain or spinal injury, history or presence of myelopathy) or neurological disorders which may mimic multiple sclerosis (MS).\n* Ongoing substance abuse (drug or alcohol) or any other factor (e.g. serious psychiatric condition) that may interfere with the participant's ability to cooperate and comply with the study procedures.\n* Participants with history of confirmed Progressive Multifocal Leukoencephalopathy (PML) or neurological symptoms consistent with PML.\n* Women of childbearing potential (WOCBP), unless they are using highly effective methods of contraception (failure rate \\\u003C 1% per year) while taking study treatment and for at least 1 week after stopping study treatment.\n* Significant bleeding risk or coagulation disorders, at Screening.\n* Use of exclusionary medication prior to Screening\u002Frandomization as listed in the protocol.\n\nOther protocol-defined inclusion\u002Fexclusion critria may apply","ALL","18 Years","65 Years",{"count":21,"type":22},1275,"ESTIMATED","INTERVENTIONAL",[25],"PHASE3","The purpose of this study is to provide efficacy and safety data for remibrutinib in patients with secondary progressive multiple sclerosis (SPMS)",[28],"Secondary Progressive Multiple Sclerosis (SPMS)",[30,31,32,33,34,35,36,37,38,39],"MS","Multiple sclerosis","secondary progressive multiple sclerosis","SPMS","remibrutinib","LOU064","adult","Expanded Disability Status Scale","EDSS","McDonald diagnostic criteria","RECRUITING","2026-07-09",{"date":43,"type":44},"2026-07-13","ACTUAL",{"date":46,"type":44},"2025-11-11",{"date":48,"type":22},"2034-01-02",{"name":50,"class":51},"Novartis Pharmaceuticals","INDUSTRY",236,{"id":54,"slug":4,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":55,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":56,"targetDuration":4,"studyType":23,"phases":57,"briefSummary":26,"conditions":58,"keywords":59,"overallStatus":40,"whyStopped":4,"lastUpdateSubmitDate":60,"lastUpdatePostDateStruct":61,"startDateStruct":63,"completionDateStruct":64,"leadSponsor":65,"locationsCount":66},"100610278","Inclusion Criteria:\n\n* Signed informed consent must be obtained prior to any assessment performed.\n* Male or female participants aged 18-65 (inclusive) at Screening.\n* Diagnosis of SPMS according to the 2017 revised McDonald criteria (Thompson et al 2018) at Screening.\n* Absence of documented clinical relapses in the 24 months before Screening and randomization.\n* EDSS score of 3.0 to 6.0 (inclusive) at Screening.\n* Documented evidence of disability progression in the 12 months before Screening.\n\nExclusion Criteria:\n\n* Unwilling or unable to undergo MRI scans as per protocol (for example, claustrophobia, or presents absolute contraindications to MRI (e.g., metallic implants, metallic foreign bodies, pacemaker, defibrillator)).\n* History of clinically significant central nervous system (CNS) disease (e.g. stroke, traumatic brain or spinal injury, history or presence of myelopathy) or neurological disorders which may mimic multiple sclerosis (MS).\n* Ongoing substance abuse (drug or alcohol) or any other factor (e.g. serious psychiatric condition) that may interfere with the participant's ability to cooperate and comply with the study procedures.\n* Participants with history of confirmed Progressive Multifocal Leukoencephalopathy (PML) or neurological symptoms consistent with PML.\n* Women of childbearing potential (WOCBP), defined as all women physiologically capable of becoming pregnant from menarche until becoming post-menopausal, unless they are using highly effective methods of contraception (failure rate \\\u003C 1% per year) while taking study treatment and for at least 1 week after stopping study treatment.\n* Significant bleeding risk or coagulation disorders, at Screening.\n* Use of exclusionary medication prior to Screening\u002Frandomization as listed in the protocol.\n\nOther protocol-defined inclusion\u002Fexclusion critria may apply",{"count":21,"type":22},[25],[28],[30,31,32,33,34,35,36,37,38,39],"2026-06-19",{"date":62,"type":44},"2026-06-23",{"date":46,"type":44},{"date":48,"type":22},{"name":50,"class":51},223,{"id":68,"slug":69,"hasResults":11,"nctId":70,"briefTitle":71,"officialTitle":72,"acronym":73,"eligibilityCriteria":74,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":75,"targetDuration":4,"studyType":23,"phases":77,"briefSummary":80,"conditions":81,"keywords":86,"overallStatus":40,"whyStopped":4,"lastUpdateSubmitDate":94,"lastUpdatePostDateStruct":95,"startDateStruct":97,"completionDateStruct":99,"leadSponsor":101,"locationsCount":103},"100629666","phase-1-treatment-of-participants-with-primary-or-secondary-progressive-multiple-sclerosis-100629666","NCT07477639","Treatment of Participants With Primary or Secondary Progressive Multiple Sclerosis","A Phase 1\u002F2a, Open-Label, Dose-Escalation Study to Evaluate the Safety and Preliminary Efficacy of TRX319 in Subjects With Primary or Secondary Progressive Multiple Sclerosis","IMPACT-MS","Inclusion Criteria:\n\n1. Clinical diagnosis of MS with evidence of PPMS or SPMS according to 2025 McDonald criteria.\n2. Expanded Disability Status Scale (EDSS) range ≥ 2.5 to ≤ 6.5.\n3. Evidence of clinical disability progression within 2 years prior to enrollment.\n4. Documented presence of CSF-restricted OCBs and\u002For elevated IgG index and\u002For κ free light chain.\n5. Males and females ≥ 18 and ≤ 65 years of age at time of consent.\n6. Evidence of adequate organ function\n7. Women of child bearing potential have a negative pregnancy test at screening.\n8. Contraceptive use by all participants while on study.\n9. Participants must be able to understand, consent, and be willing and able to complete all specified procedures and visits.\n10. Positive varicella zoster virus titer. Participants who test seronegative for varicella zoster virus IgG antibodies need to complete vaccination ≥ 4 weeks prior to TRX319 infusion.\n11. Participants must be willing to refrain from donating blood for 1 year after TRX319 infusion.\n\nExclusion Criteria:\n\n1. MS clinical stability on disease modifying therapy.\n2. Clinical relapse of MS in the 1 year prior to study entry.\n3. Diseases other than MS to explain the first demyelinating event, including aquaporin 4 IgG or myelin oligodendrocyte glycoprotein-IgG seropositivity.\n4. Prior treatment with CAR-T or gene therapy product directed at any target.\n5. Prior treatment with mitoxantrone, cladribine (or other chemotherapies), or alemtuzumab within 2 years prior to TRX319 dose.\n6. Prior treatment with CD20-depleting antibodies within 3 months and prior treatment with Bruton's tyrosine kinase inhibitor (BTKi) and sphingosine 1 phosphate (S1P) modulators within 1 month of TRX319 dose.\n7. Plan to or have received live, attenuated vaccines less than 4 weeks (28 days) prior to TRX319 infusion, and other vaccines less than 2 weeks (14 days) prior to TRX319 infusion.\n8. Serologic status reflecting active hepatitis B or C infection.\n9. Positive serology for human immunodeficiency virus (HIV).\n10. History of progressive multifocal leukoencephalopathy.\n11. Untreated active, or active with documented completed treatment but without a negative chest X-ray that shows no evidence of active tuberculosis, or latent tuberculosis.\n12. Primary immunodeficiency as defined by a known genetic disorder.\n13. History of splenectomy.\n14. Impaired cardiac function or clinically significant cardiac disease.\n15. Previous or concurrent malignancy.\n16. Prior organ transplant, or allogeneic hematopoietic stem cell transplantation or recipient of peripheral blood products \\\u003C 3 years prior to TRX319 infusion.\n17. Major surgery within 4 weeks prior or planned within 4 weeks after TRX319 administration.\n18. History of any other neurologic disorder or medical condition the Investigator considers would increase the risk for the participant, including seizure disorders.\n19. Life-threatening allergies, hypersensitivity, or documented intolerance to TRX319 drug product excipients.\n20. Subjects that are pregnant, breast feeding or aim to become pregnant during the study period (Subjects must agree to use a highly effective method of contraception).\n21. Serious and\u002For uncontrolled medical condition that, in the Investigator's judgment, would cause unacceptable safety risk, interfere with study procedures or results, or compromise compliance with the protocol.",{"count":76,"type":22},39,[78,79],"PHASE1","PHASE2","The goal of this clinical trial is to treat male and female participants with two types of Multiple Sclerosis (MS) called primary progressive or secondary progressive MS.\n\nThe main questions the trial aims to answer are the following:\n\n* Is TRX319 safe when administered to patients with progressive forms of MS?\n* At what dose does TRX319 work the best to treat participants with primary and or secondary progressive MS?\n* Is pre-conditioning (with Bendamustine) needed to allow TRX319 to better treat participants with primary and\u002For secondary progressive MS?\n\nParticipants will be asked to be on study for up 1 year and may receive up to 3 total administrations of TRX319. While on study, participants will have blood tests and other assessments (MRI scans and lumbar punctures) done to understand the safety of TRX319 and how it may benefit their multiple sclerosis.",[82,28,83,84,85],"Primary Progressive Multiple Sclerosis","Multiple Sclerosis","Multiple Sclerosis (MS) Primary Progressive","Multiple Sclerosis (MS) Secondary Progressive",[87,73,88,83,30,89,90,91,33,92,93],"TRX319-01","Tr1X","Autoimmune","Impact MS","PPMS","Primary Progressive","Secondary Progressive","2026-03-17",{"date":96,"type":44},"2026-03-19",{"date":98,"type":22},"2026-03",{"date":100,"type":22},"2029-01",{"name":102,"class":51},"Tr1X, Inc.",2,{"id":105,"slug":106,"hasResults":11,"nctId":107,"briefTitle":108,"officialTitle":109,"acronym":4,"eligibilityCriteria":110,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":111,"targetDuration":4,"studyType":23,"phases":113,"briefSummary":114,"conditions":115,"keywords":116,"overallStatus":40,"whyStopped":4,"lastUpdateSubmitDate":121,"lastUpdatePostDateStruct":122,"startDateStruct":124,"completionDateStruct":126,"leadSponsor":128,"locationsCount":131},"100562141","phase-2-the-effect-of-rituximab-on-cognitive-and-hand-functions-in-secondary-progressive-multiple-sclerosis-100562141","NCT06599307","The Effect of Rituximab on Cognitive and Hand Functions in Secondary Progressive Multiple Sclerosis","The Effect of Rituximab on Cognitive and Hand Functions in Secondary Progressive Multiple Sclerosis: a Randomized Controlled Trial","Inclusion Criteria:\n\n1. Diagnosis of secondary progressive multiple sclerosis by Lorscheider et al's criteria (disability progression by 1 EDSS step in patients with EDSS ≤ 5.5 or 0.5 EDSS step in patients with EDSS ≥ 6 in the absence of a relapse, a minimum EDSS score of 4 and pyramidal functional system (FS) score of 2 and confirmed progression over ≥3 months, including confirmation within the leading FS).\n2. Baseline EDSS ≥ 6.5.\n\nExclusion Criteria:\n\n1. Patients received disease modifying therapy for SPMS other than rituximab.\n2. Clinical relapse in the last 3 months before recruitment.\n3. Patients with documented hypersensitivity or contraindication to rituximab.\n4. Patients with concomitant neurologic conditions that may affect cognitive or hand functions.",{"count":112,"type":22},46,[79],"The goal of this clinical trial is to know if rituximab can improve cognitive and hand functions in secondary progressive multiple sclerosis (SPMS) patients with high disability (EDSS 6.5 or more). The main questions it aims to answer are:\n\nCan rituximab improve cognitive and hand functions in SPMS patients? Can rituximab improve the quality of life and the Expanded Disability Status Scale (EDSS) in SPMS patients?\n\nResearchers will compare patients who receive rituximab to patient who receive placebo to see the effects of rituximab on cognition, hand functions, quality of life and EDSS.\n\nDemographic and clinical data as age, gender, disease duration and EDSS will be obtained from each participant. Participants will perform The Brief International Cognitive Assessment for Multiple Sclerosis (BICAMS), The Nine-Hole Peg Test (9-HPT) and The MS-QLQ27 questionnaire at baseline and after one year of receiving either rituximab or placebo.",[28],[117,118,119,120],"Rituximab","Cognitive functions","Hand functions","Secondary Progressive Multiple Sclerosis","2026-03-16",{"date":123,"type":44},"2026-03-18",{"date":125,"type":44},"2024-08-01",{"date":127,"type":22},"2026-09",{"name":129,"class":130},"Cairo University","OTHER",1,{"id":133,"slug":134,"hasResults":11,"nctId":135,"briefTitle":136,"officialTitle":137,"acronym":4,"eligibilityCriteria":138,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":139,"targetDuration":4,"studyType":23,"phases":141,"briefSummary":142,"conditions":143,"keywords":144,"overallStatus":147,"whyStopped":4,"lastUpdateSubmitDate":148,"lastUpdatePostDateStruct":149,"startDateStruct":151,"completionDateStruct":153,"leadSponsor":155,"locationsCount":103},"100589974","phase-2-study-of-ng01-cell-therapy-in-secondary-progressive-multiple-sclerosis-100589974","NCT06961383","Study of NG01 Cell Therapy in Secondary Progressive Multiple Sclerosis","A Double Blind, Randomized, Placebo Controlled Phase 2b Study to Evaluate the Safety and Clinical Efficacy of Treatment With the Autologous Cell Therapy Product, NG01, in Patients With Secondary Progressive Multiple Sclerosis","Inclusion Criteria:\n\n1. Participants aged 18 to 65 years old.\n2. Diagnosis of SPMS.\n3. Documented EDSS worsening over the 2 years prior to study entry of ≥1 point for participants with EDSS \\\u003C6.0 at screening, and ≥0.5 point for participants with EDSS ≥6.0 at screening, or a documented worsening of at least 20% in the T25FW. If documented T25fW or EDSS is not available, a written summary of the clinical evidence of disability worsening over the previous 2 years and retrospective assessment of EDSS score from data up to 2 years prior to screening, must be submitted for central review by adjudication committee.\n4. EDSS at the screening visit from 3.5 to 6.5 at screening.\n5. T25FW at the screening visit of from 8.0 to 25 seconds.\n\nExclusion Criteria:\n\n1. Documented clinical relapse during the 24 months prior to enrollment and\u002For evidence of enhancing lesions on an MRI obtained at screening.\n2. Pregnancy, breast feeding or women with childbearing potential without an acceptable form of contraception.\n3. History of a general chronic handicapping\u002Fincapacitating disease other than MS.\n4. Participants with clotting disorders\n5. Participants unable to undergo an MRI scan.\n6. Participants with uncontrolled hepatic disorders, renal or cardiovascular disease, or cancer.\n7. Laboratory tests out of normal ranges considered by the investigator as clinically significant.\n8. Participants with history or current alcohol abuse or drug addiction.\n9. Untreated or uncontrolled psychiatric disorders, or positive suicidal risk assessed by Columbia-Suicide Severity Rating Scale (C-SSRS).\n10. Participation in another research study involving an investigational product (IP) in the 90 days prior to inclusion, or planned use of another IP during the study duration.\n11. Participants who have ever received NG01\u002FMSCs treatment.\n12. Participants who, in the opinion of the investigator, are unable to fully comprehend the consenting process or likely to be non-compliant with the study procedures or for whom long-term follow-up seems difficult to achieve.\n13. Relapse occurring between screening and randomization.\n14. Less than 6 months of the current disease-modifying therapy",{"count":140,"type":22},45,[79],"The goal of this clinical trial is to assess the safety and efficacy of repeated intrathecal (IT) injection of NG01, autologous bone marrow derived human stromal cells, in treating Secondary Progressive Multiple Sclerosis (SPMS), compared to placebo.\n\nThe study will assess the proportion of participants demonstrating improvement in walking ability, defined as a reduction in the average time to complete the Timed 25-Foot Walk (T25FW) at 6, 9, and 12 months compared to baseline. This will be analyzed by the mean change in walking speed across these time points. The study will also evaluate the incidence and nature of treatment-emergent adverse events (AEs).\n\nParticipants will receive intrathecal administrations of NG01, by lumbar puncture, and will be followed up for 6 months after their fourth administration.",[28],[145,31,146],"Secondary progressive multiple sclerosis","Autologous cell therapy","NOT_YET_RECRUITING","2025-04-28",{"date":150,"type":44},"2025-05-07",{"date":152,"type":22},"2025-10-01",{"date":154,"type":22},"2028-03-01",{"name":156,"class":51},"NeuroGenesis Ltd.",{"id":158,"slug":159,"hasResults":11,"nctId":160,"briefTitle":161,"officialTitle":162,"acronym":163,"eligibilityCriteria":164,"healthyVolunteers":165,"sex":17,"minAge":18,"maxAge":166,"enrollmentInfo":167,"targetDuration":4,"studyType":169,"phases":4,"briefSummary":170,"conditions":171,"keywords":176,"overallStatus":40,"whyStopped":4,"lastUpdateSubmitDate":193,"lastUpdatePostDateStruct":194,"startDateStruct":196,"completionDateStruct":198,"leadSponsor":200,"locationsCount":131},"100452900","imaging-the-interplay-between-axonal-damage-and-repair-in-multiple-sclerosis-100452900","NCT05177523","Imaging the Interplay Between Axonal Damage and Repair in Multiple Sclerosis","INsIDER: Imaging the Interplay Between Axonal Damage and Repair in Multiple Sclerosis","INsIDER","Inclusion Criteria for patients:\n\n* Patients may be diagnosed with:\n\n  1. active RRMS (n=100): Relapsing-remitting course and \\> 1 clinical relapse and\u002For signs of MRI activity (\\> 1 Gd enhancing lesion) during the last year before study enrollment.\n  2. non-active PMS (n=100): Progressive course (PPMS or SPMS) and no clinical relapses and\u002For signs of MRI activity during the last year before study enrollment.\n* Age 18-80 years old\n* No other neurological or psychiatric disorder\n\nInclusion criteria for healthy controls:\n\n* Age 18-80 years old\n* No other neurological or psychiatric disorder\n\nExclusion Criteria for patients and healthy controls:\n\n* Pregnancy\n* Contraindication to MRI (eg, claustrophobia, metallic implants, pacemaker etc).\n* Inability to give consent",true,"80 Years",{"count":168,"type":22},300,"OBSERVATIONAL","This project is to:\n\n1. Quantify differences in axonal integrity and organization in aMS versus naPMS patients.\n2. Quantify changes in axonal integrity and organization in aMS versus naPMS patients over a two-year period.\n3. Validate the combination of imaging parameters that best differentiate aMS versus naPMS patients using histopathology.",[172,173,174,175],"Multiple Sclerosis (MS)","Relapsing-remitting Multiple Sclerosis (RRMS)","Secondary-progressive Multiple Sclerosis (SPMS)","Primary Progressive Multiple Sclerosis (PPMS)",[177,178,179,180,181,182,183,184,185,186,187,188,189,190,191,192],"axonal damage","axonal demyelination","axonal degeneration","axonal loss","axonal disorganization","axonal repair","axonal remyelination","axonal reorganization","Advanced MRI (aMRI)","Neurite Orientation Dispersion and Density Imaging (NODDI)","Diffusion Kurtosis (DK)","Magnetization Transfer Imaging (MTI)","Multi-echo Susceptibility-Based imaging (SBI)","Myelin Water Imaging (MWI)","T1 relaxometry (quantitative T1, qT1)","machine learning technique","2024-12-13",{"date":195,"type":44},"2024-12-16",{"date":197,"type":44},"2018-09-04",{"date":199,"type":22},"2028-12",{"name":201,"class":130},"University Hospital, Basel, Switzerland"]